Triplex (CMV-MVA vaccine) / Fortress - LARVOL DELTA

CMV-MVA Triplex Vaccination of Stem Cell Donors in Preventing CMV Viremia in Participants With Allogeneic Transplant (clinicaltrials.gov) - P1 | N=34 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Aug 2025 ➔ Jul 2026

Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Cytomegalovirus Infection • Hematological Malignancies • Leukemia • Lymphoma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

Multi-antigen CMV-MVA Triplex Vaccine in Reducing CMV Complications in Patients Previously Infected With CMV and Undergoing Donor Hematopoietic Cell Transplant (clinicaltrials.gov) - P2 | N=102 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Jul 2025 ➔ Jun 2026

Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Cytomegalovirus Infection • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • HLA-DRB1

A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant (clinicaltrials.gov) - P1 | N=46 | Not yet recruiting | Sponsor: City of Hope Medical Center

New P1 trial • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

CMV-MVA Triplex Vaccination of Stem Cell Donors in Preventing CMV Viremia in Participants With Allogeneic Transplant (clinicaltrials.gov) - P1 | N=34 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2024 ➔ Aug 2025

Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Cytomegalovirus Infection • Hematological Malignancies • Leukemia • Lymphoma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

Allogeneic CMV-Specific CD19-CAR T Cells Plus CMV-MVA Triplex Vaccine After Matched Related Donor Hematopoietic Cell Transplant for the Treatment of Patients With High-Risk Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: City of Hope Medical Center | Not yet recruiting ➔ Recruiting | Trial completion date: May 2028 ➔ Mar 2029 | Trial primary completion date: May 2028 ➔ Mar 2029

Enrollment open • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • Transplantation

CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant (clinicaltrials.gov) - P2 | N=216 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Jan 2028 ➔ Jan 2029 | Trial primary completion date: Jan 2027 ➔ Jan 2028

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Cytomegalovirus Infection • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • HLA-DRB1

Multi-antigen CMV-MVA Triplex Vaccine in Reducing CMV Complications in Patients Previously Infected With CMV and Undergoing Donor Hematopoietic Cell Transplant (clinicaltrials.gov) - P2 | N=102 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2024 ➔ Jul 2025

Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Cytomegalovirus Infection • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • HLA-DRB1

Fortress Biotech Announces First Patient Dosed in Phase 2 Clinical Trial of Triplex Vaccination in Stem Cell Donors to Reduce CMV Events in Recipients of HSCT (GlobeNewswire) - "Fortress Biotech, Inc...today announced that the first patient was dosed in a multicenter, placebo-controlled and randomized Phase 2 clinical trial to evaluate Triplex, a cytomegalovirus ('CMV') vaccine, when administered to human leukocyte antigen ('HLA') matched related stem cell donors to reduce CMV events in patients undergoing hematopoietic stem cell transplantation ('HSCT')."

Trial status • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma

Allogeneic CMV-Specific CD19-CAR T Cells Plus CMV-MVA Triplex Vaccine After Matched Related Donor Hematopoietic Cell Transplant for the Treatment of Patients With High-Risk Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: City of Hope Medical Center

CAR T-Cell Therapy • New P1 trial • Triplex vaccine • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • Transplantation

Triplex Vaccine in Preventing CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplantation (clinicaltrials.gov) - P2 | N=7 | Active, not recruiting | Sponsor: City of Hope Medical Center | N=12 ➔ 7

Enrollment change • Triplex vaccine • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Cytomegalovirus Infection • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

Multi-antigen CMV-Modified Vaccinia Ankara Vaccine in Treating Pediatric Patients With Positive Cytomegalovirus Undergoing Donor Stem Cell Transplant (clinicaltrials.gov) - P1/2 | N=80 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Nov 2024 ➔ Dec 2026 | Trial primary completion date: Nov 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Bone Marrow Transplantation • Cytomegalovirus Infection • Infectious Disease • Pediatrics • Transplantation • HLA-DRB1

IRB 19065 - CMV-MVA Triplex Vaccine After Letermovir in HCT Recipients (clinicaltrials.gov) - P=N/A | N=136 | Not yet recruiting | Sponsor: City of Hope Medical Center

New trial • Triplex vaccine • Bone Marrow Transplantation • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Transplantation

CMV-MVA Triplex Vaccination of Stem Cell Donors in Preventing CMV Viremia in Participants With Allogeneic Transplant (clinicaltrials.gov) - P1 | N=34 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Jun 2024 ➔ Dec 2024

Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Cytomegalovirus Infection • Hematological Malignancies • Leukemia • Lymphoma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant (clinicaltrials.gov) - P2 | N=216 | Recruiting | Sponsor: City of Hope Medical Center | Initiation date: Apr 2024 ➔ Aug 2024

Trial initiation date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Cytomegalovirus Infection • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • HLA-DRB1

CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant (clinicaltrials.gov) - P2 | N=216 | Recruiting | Sponsor: City of Hope Medical Center | Not yet recruiting ➔ Recruiting | Trial completion date: Aug 2025 ➔ Jan 2028 | Trial primary completion date: Aug 2025 ➔ Jan 2027

Enrollment open • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Cytomegalovirus Infection • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • HLA-DRB1

Multi-antigen CMV-MVA Triplex Vaccine in Reducing CMV Complications in Patients Previously Infected With CMV and Undergoing Donor Hematopoietic Cell Transplant (clinicaltrials.gov) - P2 | N=102 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Triplex vaccine • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Cytomegalovirus Infection • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • HLA-DRB1

Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV-MVA Triplex) Following Stem Cell Transplantation for the Treatment of Intermediate or High Grade B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Apr 2027 ➔ Dec 2028 | Trial primary completion date: Apr 2026 ➔ Mar 2028

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

CMV-MVA Triplex Vaccination of Stem Cell Donors in Preventing CMV Viremia in Participants With Allogeneic Transplant (clinicaltrials.gov) - P1 | N=34 | Active, not recruiting | Sponsor: City of Hope Medical Center | Phase classification: P2 ➔ P1 | Trial completion date: Dec 2023 ➔ Jun 2024

Phase classification • Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Cytomegalovirus Infection • Hematological Malignancies • Leukemia • Lymphoma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV-MVA Triplex) for the Treatment of Intermediate or High Grade B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Sep 2026 ➔ Dec 2028 | Trial primary completion date: Sep 2026 ➔ Mar 2028

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Triplex vaccine • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant (clinicaltrials.gov) - P2 | N=216 | Not yet recruiting | Sponsor: City of Hope Medical Center | Initiation date: Dec 2023 ➔ Apr 2024

Trial initiation date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Cytomegalovirus Infection • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • HLA-DRB1

Triplex Vaccine in Preventing CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplantation (clinicaltrials.gov) - P2 | N=12 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Apr 2025 ➔ Apr 2030 | Trial primary completion date: Apr 2025 ➔ Apr 2030

Trial completion date • Trial primary completion date • Triplex vaccine • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Cytomegalovirus Infection • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant (clinicaltrials.gov) - P2 | N=216 | Not yet recruiting | Sponsor: City of Hope Medical Center

New P2 trial • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Cytomegalovirus Infection • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • HLA-DRB1

Multi-antigen CMV-Modified Vaccinia Ankara Vaccine in Treating Pediatric Patients With Positive Cytomegalovirus Undergoing Donor Stem Cell Transplant (clinicaltrials.gov) - P1/2 | N=80 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Aug 2023 ➔ Nov 2024 | Trial primary completion date: Aug 2023 ➔ Nov 2024

Trial completion date • Trial primary completion date • Triplex vaccine • Bone Marrow Transplantation • Cytomegalovirus Infection • Infectious Disease • Pediatrics • Transplantation • HLA-DRB1

Multi-antigen CMV-Modified Vaccinia Ankara Vaccine in Treating Pediatric Patients With Positive Cytomegalovirus Undergoing Donor Stem Cell Transplant (clinicaltrials.gov) - P1/2 | N=80 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: May 2023 ➔ Aug 2023 | Trial primary completion date: May 2023 ➔ Aug 2023

Trial completion date • Trial primary completion date • Triplex vaccine • Bone Marrow Transplantation • Cytomegalovirus Infection • Infectious Disease • Pediatrics • Transplantation • HLA-DRB1

Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV-MVA Triplex) for the Treatment of Intermediate or High Grade B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: City of Hope Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • EGFR • IFNG • TNFRSF9